MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.Device not returned for evaluation.

Event Description

It was reported that after insertion, the catheter did not seem to have been properly inserted into the blood vessel, so the catheter was removed.However, the catheter was cut during removal, so the catheter remaining in the blood vessel was removed by the procedure.

Manufacturer Narrative

H11: section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a damaged powerglide pro catheter was confirmed.The product returned for evaluation was one 20ga x 10cm powerglide pro midline catheter assembly.The catheter was advanced and the safety mechanism was engaged over the needle tip.Usage residues were observed throughout the sample.The catheter terminated 5.7cm from the molded joint.The break in the catheter shaft appeared irregular.The distal catheter fragment was not returned.Microscopic inspection of the break in the catheter revealed a sharply defined fracture surface.The break exhibited a tapered profile.A longitudinally aligned scoring mark was observed on the inside surface of the catheter leading into the break.The break features and longitudinal scoring mark were typical of damage caused by contact between the catheter and the needle tip.Such damage can occur if the catheter is withdrawn on to the needle and if the needle is re-inserted following catheter advancement.The product ifu states ¿warning: once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle.If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter.¿.

Event Description

It was reported that after insertion, the catheter did not seem to have been properly inserted into the blood vessel, so the catheter was removed.However, the catheter was cut during removal, so the catheter remaining in the blood vessel was removed by the procedure.

• Brand Name: 20 GAUGE POWERGLIDE PRO MIDLINE CATHETER 10CM BASIC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 11966374
• MDR Text Key: 255114793
• Report Number: 3006260740-2021-02233
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: K162377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 6F120100
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention